510(k) Report

FDA applicant

Biocore9, LLC

Whippany, NJ3 decisions2020–20220 recalls

FDA records 3 decisions for Biocore9, LLC (Whippany, NJ) from 2020 to 2022: 3 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and KXA (Prosthesis, Hip, Femoral, Resurfacing). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Biocore9, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12021: 12022: 1
2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Biocore9, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision
  • KXAProsthesis, Hip, Femoral, Resurfacing1decision
  • HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212761Biocore9 Acetabular Cup SystemBiocore9, LLC · 2022
  • K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLC · 2021
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020

All 3 as Biocore9, LLC →